Commercial Manufacturing

GMP & Chemical Manufacturing

Syngene has exclusive capabilities for GMP and chemical manufacturing from bench top volume to commercial scale and is also further expanding to cater to the growing demands. Depending on the end application, the manufacturing is done in an appropriate facility at Syngene. Our uncompromised commitment to safety and regulatory compliance helped Syngene to be the trusted partner for several global customers.

Our scale up activities are performed by a team of experienced chemical manufacturing personnel operating 24x7 and well supported by Quality Control, Quality Assurance, Environment Health Safety and Sustainability, Engineering and Maintenance and Supply Chain Management functions.

Experience with Complex Chemistry Capabilities:

We have proven track record and expertise to handle a wide range of complex chemical conversion and reagents on scale with few examples listed below:

Asymmetric catalysis

Suzuki reaction

Heck reaction

Sonagashira reaction

Methylation

Halogenation (bromine)

Grignard reactions

Cyclopropanation

Epoxidation

Oxidation

Grubb’s catalyst

Diethyl aluminium chloride

Diethyl zinc

DIBAL

Organometallics (LDA, n-BuLi etc.)

Borane

Process and analytical validation

Validation is the key element to any development program. Syngene is well versed in performing process validation studies for intermediates, APIs and HPAPIs. Our experience is reflected in a straight forward strategy that is followed at the right stage of the development.

Design and control of manufacturing processes to assure, in-process materials and product meet predetermined quality requirements consistently and reliably.